MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION®; DIMENSION® FT4 FREE THYROXINE FLEX REAGENT CARTRIDGE

Catalog Number RF410 SMN10444910

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Siemens customer support determined that the aeration ball on the water filtration system was not working properly.The customer contacted the water filtration vendor and replaced the aeration ball.The cause for the discordant falsely low ft4 result is unknown.The device is performing within specifications.No further evaluation of the device is required.

Event Description

A discrepant low free thyroxine (ft4) result was obtained on a patient sample on the dimension xpand system.The patient result was reported to the physician who questioned the result.The same sample was sent for testing at an alternate laboratory and run using a different methodology.A higher result was obtained.The physician regarded the higher result as correct.There is no indication that patient treatment was altered or prescribed on the basis of the discrepant low ft4 result.There was no report of adverse health consequences as a result of the discrepant low ft4 result.

• Brand Name: DIMENSION®
• Type of Device: DIMENSION® FT4 FREE THYROXINE FLEX REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 6057774
• MDR Text Key: 58411399
• Report Number: 2517506-2016-00342
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2017
• Device Catalogue Number: RF410 SMN10444910
• Device Lot Number: GB7166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1